Documentation Management Specialist

9/2017 – offen

• Assist the CSV managers and experts to organize the documentations during the CSV lifecycle based on the GAMP 5. (Firstdoc, PTCwindchill and d3)
• Arrange the training structure at learning management system for the validated systems at clients.
• Control and train the change management process in electronic documentation system (First-doc and PTC-windchill)

GxP

4/2013 – 12/2014

• Preparing the regulatory documentation for different products for the different regions based on authorities’ requests.
• Arrange all the procurement paper-based documentation system
• Transferring the financial documents from paper to electronic base system.

GxP

1/2009 – 2/2012

• Budget controlling the site office
• Correlating different site clients and fellow contractors
• Managing service staff and general services

Enterprise project management (EPM)